Kornimate/medical-research-clean huggingface dataset:
growth and development-related outcomes in children with transfusion-dependent beta-thalassemia after gene therapy

Conditions: Transfusion-dependent Beta-Thalassemia; Gene Therapy

Summary: the investigate will conduct a cohort study to compare the growth and development, metabolism, lifestyle behavior, and health-related quality of life among three groups: children with transfusion-dependent β-thalassemia (tdt) who have received gene therapy, tdt children with lifelong supportive therapy and healthy children.


Eligibility criteria:
inclusion criteria: gene therapy group-inclusion * male or female age of 3-14 years * tdt children who have received gene therapy. * subjects who are willing and able to provide written informed consent. supportive therapy group-inclusion * gender same as the matched case * age similar to the matched case * children with β-tdt * no history of gene therapy or allogeneic hematopoietic stem cell transplantation * subjects who are willing and able to provide written informed consent. healthy children group-inclusion * gender same as the matched case * age similar to the matched case * subjects who are willing and able to provide written informed consent. exclusion criteria: * diagnosis of compound α-thalassemia * uncontrolled systemic fungal, bacterial, or viral infection * history of malignant solid tumors, myeloproliferative or immunodeficiency diseases * diagnosed with mental illness * patients considered to be ineligible for the study by the investigator for reasons other than the above discontinuation of study : * subjects who are unwilling or unable to continue participating in the study (withdrawal of informed consent) may withdraw from the study * subjects who received gene therapy or allogeneic hematopoietic stem cell transplantation during the study * the subject is seriously non-compliant with the study requirements, such as missing 2 consecutive visits * subject lost to follow-up

Keywords: transfusion-dependent beta-thalassemia gene therapy cohort study case-control
rapid first contact using virtual visits to improve time-to-treatment for uterine cancer

Conditions: Uterine Cancer

Summary: this project aims to evaluate whether rapid first contact with the oncologist the same day or the next day after pathologic diagnosis contributes to a decreased time to treatment, decreased patient anxiety and increased patient satisfaction.

time to treatment (time from disease diagnosis to initiation of treatment) impacts outcomes in uterine cancer. when controlled for stage, patients with longer time to treatment tend to have less favorable outcomes. similarly, longer time to treatment has a negative impact on patients' quality of life and markers for anxiety. our experience at this institution suggests that the time to referral (time from uterine cancer diagnosis and the patients' first encounter with the oncologist) is variable and presents the greatest opportunity for decreasing time to treatment. among the factors that contribute to the time to referral are the time taken by the referring provider to relay the diagnosis to the patient, time taken to schedule an appointment with the specialist, and the patient's availability to keep an appointment. virtual visits provide an opportunity to expedite consultation with the treating oncologist by removing some of the barriers that delay face-to-face visits. among these barriers are patients' availability for a short notice face-to-face visit based on their work or family obligations, access to transportation, and mental preparedness.

Eligibility criteria:
inclusion criteria: * uterine cancer diagnosis on biopsy read by cleveland clinic pathology department * patients must be willing to participate in a virtual visit as the initial meeting with an oncologist at the cleveland clinic. * receive care at fairview hospital, hillcrest hospital or cleveland clinic main campus * internet connected smartphone or internet connected computer with webcam * participants must have email access * english speaking * competent to make clinic decisions exclusion criteria: * no diagnosis of uterine cancer
post marketing surveillance of alesion® in japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus

Conditions: Rhinitis, Allergic, Perennial

Summary: study to investigate the safety and efficacy of alesion® dry syrup under the proper use in daily clinical practice in japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus


Eligibility criteria:
inclusion criteria: * all the patients who: * haven't treatment experience of epinastine product; * have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, urticaria exclusion criteria: * alesion® dry syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of alesion® dry syrup in package insert. however, it was unknown whether a patient was hypersensitive to the ingredients of the product in almost cases. and this survey was drug utilization study to observe actual use in any patients. therefore exclusion criteria are not set in the protocol
digital health intervention on awareness of vaccination against influenza among adults with diabetes

Conditions: Diabetes Mellitus Self Management Education; Diabetes

Summary: the study leveraged the dario digital health platform to retrospectively analyze data from 64,904 users with diabetes assigned by the platform into three groups: group a received previously studied monthly flu nudge messages; group b received an adapted intervention with 2-3 monthly messages; group c served as the control with no intervention. surveys were conducted at baseline, three months, and six months to assess vaccination status, awareness of influenza risks, and recollection of educational content. statistical analyses, including logistic regression, chi-square tests, and t-tests, were used to evaluate differences between groups.

the goal of this study was to retrospectively evaluate the effectiveness of an adapted digital nudge intervention that was designed previously in an rct setting to increase influenza vaccination rates for pwd in real world setting. the primary objective was to examine the difference in self-reported influenza vaccination rates in three groups: pwd who received the intervention using a previously published approach (group a), pwd who received an adapted digital intervention (group b) and pwd who received no intervention (group c or control). a secondary aim was to investigate whether the intervention led to differences in awareness and knowledge across study groups and examined the relationship between awareness of influenza risks and vaccination rates. the data was collected between september 2022 and march 2023 to evaluate the effectiveness of an adapted digital nudge intervention designed to increase influenza vaccination rates among people with diabetes (pwd) in a real-world setting. the intervention builds on a previously conducted randomized controlled trial (rct). users were automatically assigned to three groups via the customer engagement platform using a randomization algorithm to assign each selected user to one of the test variations. this ensured that each user had an equal chance of being placed in any of the groups. the three groups are defined as follows: group a received flu nudge messages as described previously in a randomized clinical trial with one message given each month for six months; group b received similar messages that were adapted in frequency with 2-3 messages per month for six months and matched the dario platform's user experience; group c received no flu nudges (control). no compensation was offered. the intervention messages included education and recommendations related to the importance of getting flu vaccination in the diabetes population.

Eligibility criteria:
inclusion criteria: subjects from the united states utilizing a dario application who reported in the app during registration that they had a diagnosis of type 1 or 2 diabetes and who were active on the platform (logged into the app) during the 12-month period up to sep 2022. exclusion criteria: subjects that are not using dario platform

Keywords: digital health; diabetes management; influenza vaccination; flu vaccination awareness
aneurysm study of pipeline in an observational registry

Conditions: Brain Aneurysm

Summary: the primary objective of this study is to further expand the body of clinical knowledge in patients undergoing pipeline embolization device (pipeline or ped) placement for intracranial aneurysms (ias or icas) according to pipeline's labeled indication.


Eligibility criteria:
inclusion criteria: (all sites, all countries) 1. at least 1 pipeline placed for treatment of an ica 2. patient or patient's legally authorized representative (lar) has signed an irb- or ec-approved informed consent form, if required 3. patient is willing and able to comply with follow-up visits united states: additional inclusion criteria for subjects enrolled in the united states: 4us) subjects who are age 22 or higher 5us) ia of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments canada: additional inclusion criteria for subjects enrolled in canada: 4c) in canada, the pipeline™ embolization device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping. 5c) canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter. france: additional inclusion criteria for subjects enrolled in france: 4f) unruptured ia, saccular or fusiform with an aneurysm sac diameter \> 15mm and not treatable with other current therapies ( evt with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology. 5f) ia previously treated with unruptured recanalization of the aneurismal sac \> 7 mm, not treatable with conservative treatment. exclusion criteria: (based on contraindications ped ifu) 1. active bacterial infection 2. a patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated 3. a patient who has not received dual antiplatelet agents prior to the procedure 4. pre-existing stent is in place in the parent artery at the target aneurysm location 5. angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing 6. acutely ruptured aneurysm, defined as rupture of the target aneurysm each site should refer to their country specific instructions for use/approval(france) to determine final eligibility into the aspire registry.

Keywords: brain aneurysm
insulin therapy in chronic obstructive pulmonary disease (copd) exacerbations

Conditions: Chronic Obstructive Pulmonary Disease; Hyperglycemia

Summary: the purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease.

hyperglycaemia is associated with increased morbidity and mortality in patients admitted to hospital with acute critical illness, myocardial infarction and stroke. moreover patients with hyperglycaemia have a significantly longer hospital stay, higher rates of icu admission, increased in-hospital mortality and are more likely to require transfer to a nursing home. recently, interventional studies have linked reversal of hyperglycaemia to better clinical outcomes especially in acute myocardial infarction, cardiac surgery and in critically ill patients. in england and wales, it is estimated that the number of people with copd is approaching 1.5 million. the morbidity and economic costs associated with the condition are extremely high with approximately 10% of all acute medical admissions caused by exacerbations of the underlying condition. as a corollary about 15% of patients with copd need admission to hospital each year. acute hyperglycaemia is common among patients admitted with acute exacerbations of copd. the reasons for this are likely to be multi-factorial including an association between copd and increased risk of developing diabetes at least in women, the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia. admission hyperglycaemia (\>11 mmol/l) also appears to predict increased morbidity for patients with copd admitted to intensive care. the trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with copd who may or may not have diabetes. patients will take part in the trial for the first 5 days during their hospital stay.

Eligibility criteria:
inclusion criteria * patients who are not diabetic, admitted with copd who are likely to be prescribed corticosteroids as part of usual care with an admission glucose level (before steroids) between 6.1 and 11.1 mmol/l. exclusion criteria: * patients with diabetes mellitus * patients who are nil by mouth. * patients with severe co-morbid disease with an anticipated life expectancy of \< 6 months. * patients who are unable to provide informed consent. * age \<18 years.

Keywords: chronic obstructive pulmonary disease corticosteroid induced hyperglycaemia insulin
constructing and evaluating the effectiveness of a community-based older adults dementia prevention education program

Conditions: Dementia

Summary: this study adopted a mixed-methods approach and was conducted in two exploratory phases. the first phase focused on development and involved three focus group interviews with community-dwelling older adults. these qualitative focus group discussions were used to inform the development of a dementia prevention education program based on the analysis results. in the second phase, community-dwelling older adults were recruited to participate in the study. the experimental group received the dementia prevention education program, while the control group received general health education leaflets. participants were assessed before the intervention, immediately after the intervention, and again three months later. the assessments measured changes in dementia-related knowledge, dementia-related worry, health beliefs, and willingness to engage in preventive actions. this study aimed to examine the effects of the intervention on older adults' dementia knowledge, health beliefs, and willingness to undertake preventive actions.


Eligibility criteria:
inclusion criteria: (1) 55 years old or above; (2) conscious and able to speak mandarin and taiwanese; and (3) willing to participate in this study and complete the consent form - exclusion criteria:(1) diagnosed with dementia; or (2) diagnosed with severe physical or mental illness by a physician. -

Keywords: dementia prevention health beliefs
effect of flaxseed on lipid uptake and appetite

Conditions: Obesity

Summary: randomized trial to test the effect of flaxseed fractions on appetite regulation and intestinal lipid absorption.

randomized multiple crossover trial in 18 healthy males aged 18 to 40 years each are required to complete a total of five iso-caloric meal tests lasting approximately 8½ hours. test meals will be given as breakfast meals, in which different fractions of flaxseeds are incorporated into baked products. appetite will be registered using visual analogue scales during 7 hours after the test meal and a total of 10 blood samples will be drawn to evaluate tag in chylomicrons, plasma ldl, hdl and total cholesterol, plasma tag, insulin, glucose and appetite hormone levels. at the end of the test day an ad libitum meal will be served and food intake registered.

Eligibility criteria:
inclusion criteria: * healthy males aged 18-40 years * normal weight or moderately overweigh (bmi 25-30 kg/m2) exclusion criteria: * blood drawing/donation less than six months prior to start of the study * hemoglobin concentration \<8mmol/l * chronic diseases (i.e. diabetes, cvd), hypertension, hyperlipidemia * consumption of dietary supplements including vitamin tablets * smoking * excess physical activity (\>10h of intense physical activity per week) * medicine use (not including occasional consumption of pain killers)

Keywords: fat absorption fibres
clinical study of ametinib combined with bevacizumab in first-line treatment of advanced nsclc with egfr-mutations.

Conditions: Non-small Cell Lung Cancer

Summary: to explore the intracranial/extracranial orr, pfs, qol, safety, dynamic changes of tissue, cerebrospinal fluid, and plasma dna in patients with newly diagnosed advanced nsclc with egfr mutation with/without brain metastasis given first-line treatment with almonertinib combined with bevacizumab at the initial stage of treatment, during treatment and after drug resistance, and the correlation between early clearance of sensitive mutations and survival.

this is a one-arm prospective study to evaluate the first-line treatment of amitinib in combination with bevacizumab in patients with advanced nsclc with egfr mutations effectiveness and safety. subjects received amitinib and bevacizumab during the treatment cycle and were evaluated for efficacy every 6-8 weeks. subject receives medication until disease progression, intolerable toxicity, or withdrawal of informed consent. the primary endpoint was progression-free survival as measured by the solid tumor response assessment criteria (recist v1.1). primary endpoints included objective response rate (orr), progression-free period (pfs), and secondary endpoints included objective response rate (iorr), progression-free period (ipfs), overall survival (os), quality of life (qol), and safety.

Eligibility criteria:
inclusion criteria: * male or female, ≥18 years old and ≤75years old; * non-squamous non-small cell lung cancer (nsclc) confirmed by pathology (including histology or cytology); ③ egfr mutation positive (exon 19 deletion or exon 21 l858r mutation); (4) ≥3 intracranial metastases, asymptomatic brain metastases; (5) never received antitumor therapy before; * there was at least 1 measurable intracranial and extracranial lesion in ct/mri according to recist1.1 criteria. ⑦ predicted survival ≥3 months; ⑧ ecog score 0-1; ⑨ the main organs (liver, kidney, heart) function normally. ⑩ sign informed consent forms. exclusion criteria: * the intracranial metastases were oligometastases; * there are symptoms of increased intracranial pressure; (3) previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (4) patients with hypertension and can not be reduced to the normal range after antihypertensive drug treatment, have grade i coronary heart disease, grade i arrhythmia and grade i cardiac insufficiency; * patients with definite tendency to gastrointestinal bleeding; ⑥ with hemoptysis symptoms; ⑦ abnormal coagulation function (inr\>1.5, aptt\>1.5 uln), with bleeding tendency; ⑧ have a history of psychotropic drug abuse and can not abstain or have mental disorders; ⑨according to the investigator's judgment, patients who have a serious concomitant disease that endangers the patient's safety or affects the patient's completion of the study, and who have previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function.

Keywords: non-small cell lung cancer
rapid diagnostics for upper respiratory infections in the emergency department

Conditions: Respiratory Tract Infections; Influenza, Human; Common Cold

Summary: this is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ed) patients with symptoms of influenza-like illness (ili) and/or upper respiratory infection (uri).

this is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ed) patients with symptoms of influenza-like illness (ili) and/or upper respiratory infection (uri). the intervention is a rapid, multi-respiratory pathogen nucleic acid amplification panel test (filmarray respiratory panel; biofire diagnostics, llc) with clinical result reporting within two hours of sample collection. randomization is at the individual patient level. intervention patients will receive usual care plus the rapid multi-respiratory pathogen test. control patients will receive physician-directed usual care without the rapid, multi-respiratory pathogen test, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory. the primary outcome is antibiotic administration or prescription during the initial ed episode of care. the investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention patients, relative to control patients (usual care). the investigators secondary outcome is administration or prescription of antivirals during the initial ed episode of care. the investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza medication use in intervention patients (composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients), relative to control patients receiving usual care alone.

Eligibility criteria:
inclusion criteria: * university of california, davis (uc davis) emergency department patients evaluated for influenza like illness and/or upper respiratory infection by an ed physician who consent and agree to have a nasopharyngeal swab collected for the study * english speaking or spanish speaking patients exclusion criteria: * neonates * prisoners * employees of uc davis/students of the principal investigator or co-principal investigator * non-english, non-spanish speaking patients

Keywords: respiratory tract infections influenza, human common cold viral infection pathology, molecular molecular diagnostics diagnostic testing clinical microbiology polymerase chain reaction antibiotic stewardship antimicrobial use emergency department emergency room
otx-14-002: device exposure registry

Conditions: Endophthalmitis

Summary: the objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the fda-approved resure sealant when used by a broad group of physicians under commercial use conditions


Eligibility criteria:
all patients that receive at least one application of the resure sealant on the operative eye following cataract surgery will be enrolled.